Table 1.

Summary of issues identified and proposed solutions

Issues identified	Potential consequences for the study	Proposed solutions
Weakness of definitions of ICU diseases	Difficult to demonstrate trial and/or drug efficacy	Increase basic research, for example, on biomarkers
Current trial designs unadapted to ICU specificities	Lower impact of results and efficacy of trial	Adaptive design Personalized medicine
80 % of patients recruited by 20 % of sites	Possible bias, center effect	Improved site selection
Overestimation of recruitment capacity	Recruitment objectives not met, study closed	More precise calculation of recruitment capacity Evaluation of prior performance
Competing trials not considered during feasibility	Patients eligible for several studies	Tracking tables of all studies even potential
Caregivers not involved in research	Possible bias due to lack of information	Involvement of every member of the unit
Numerous players	Confusion, delay or lack of information	Standard operating procedures with different units Regular meetings
Under recruitment	Study closed for lack of patients	Research team available 24/7 Systematic screening procedures Clinical coordinating center
Complex and tight schedule of events	Missing data, delay	Computerized medical records Automatic alerts for results or treatment
Long-term follow-up of patients	Many patients lost to follow-up	Tracking tables with reminders
Lack of training for physicians	Physicians do not feel involved	Training included as soon as medical studies Specific training courses
Lack of involvement of investigators in pharmaceutical-sponsored trials	Design unadapted to ICU research Investigators do no feel involved	Involvement of physicians since the beginning of the process
Clinical research still considered as a stand-alone activity	Cares and treatments competing with routine	Clinical research implemented as part of routine care